Senior Regulatory Affairs Manager

QuidelOrtho

2d • $150,000 - $170,000 • Remote

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Regulatory Affairs Manager. The Senior Regulatory Affairs Manager is responsible for driving the planning, execution, and delivery of regulatory activities supporting clinical laboratory and transfusion medicine products across development and lifecycle stages. This role partners closely with cross-functional teams and global regulatory stakeholders to ensure timely submissions, regulatory compliance, and alignment with product development objectives.
Serving as a key contributor to regulatory strategy, the Sr RA Manager translates regulatory requirements into actionable plans, manages timelines and deliverables, and identifies risks while supporting informed decision-making. This role also ensures high-quality preparation and submission of scientifically sound regulatory documentation to health authorities, including FDA, EU Notified Bodies, and international agencies.
The Sr Regulatory Affairs Manager plays a critical role in enabling operational excellence, maintaining compliance with evolving global regulations (including EU IVDR requirements), and contributing to continuous improvement initiatives within the regulatory function, while supporting team collaboration and development.
The Senior Regulatory Affairs Manager develops, communicates, and executes regulatory strategies for clinical laboratory and transfusion medicine products across development and lifecycle management. This role supports regulatory operations and strategic initiatives while collaborating with cross-functional teams and global regulatory partners to ensure compliance and timely product registrations. The position contributes to regulatory excellence by aligning program deliverables with organizational goals and maintaining awareness of regulatory risks and requirements.
The Senior Regulatory Affairs Manager is responsible for planning, tracking, and delivering regulatory milestones, ensuring alignment with project timelines, and supporting leadership in identifying and escalating key regulatory risks and compliance issues.
This position is remote eligible for candidates located in the United States.

Requirements

• Bachelor’s degree required
• 7 years plus of extensive experience in regulatory affairs within the medical device or diagnostics industry
• Proven track record as RA Functional Core Team Lead, and managing complex regulatory submissions
• Strong background in FDA, EU IVDR, and international regulatory requirements
• Deep understanding of FDA regulations, EU IVDR, and international regulatory requirements
• Knowledge of product registration processes and compliance requirements
• Experience with regulatory submissions including 510(k), PMA, BLA, and TDF CE marking processes
• Understanding of clinical performance studies and regulatory documentation requirements
• Advanced program and project management expertise, with a track record of successfully managing multiple, concurrent priorities in fast-paced, cross-regulatory environments
• Exceptional communication and presentation skills, with the ability to translate complex regulatory concepts for both technical and non-technical stakeholders
• Proven ability to drive alignment and execution through effective collaboration across cross-functional teams, including R&D, clinical, quality, operations, legal, and commercial functions
• Ability to develop and implement regulatory strategies aligned with business objectives
• Strong analytical skills for risk assessment and strategic option evaluation
• Understanding of global regulatory landscapes and market requirements

Nice To Haves

• Advanced degree preferred in relevant scientific, regulatory, or related field
• Experience with clinical laboratory devices and transfusion medicine products

Responsibilities

• Interpret applicable regulatory requirements and apply them to project-level strategies to support compliance and product registration
• Maintain and update regulatory plans, ensuring alignment with evolving project needs and regulatory expectations
• Assess risks, trade-offs, and strategic options, and communicate recommendations to project teams and management
• Track regulatory commitments and ensure timely execution across assigned programs
• Support preparation and coordination of regulatory activities in partnership with internal teams and external stakeholders
• Prepare, review, and submit regulatory filings (e.g., FDA submissions, EU Technical Files, and international dossiers) in accordance with applicable requirements
• Ensure documentation is complete, accurate, scientifically sound, and compliant with regulatory standards
• Monitor, assess, and communicate changes in global regulations, guidance, and standards relevant to assigned product areas
• Provide regulatory input and guidance to project teams during product development and lifecycle management
• Collaborate with international regulatory colleagues to support global submissions and approvals
• Collaborate with regulatory leadership to support team objectives and resource planning
• Provide guidance and mentorship to junior regulatory staff as needed
• Coordinate activities with consultants, contractors, and external partners
• Promote a culture of continuous improvement and knowledge sharing within the regulatory function
• Support compliance with EU IVDR requirements, including maintenance of technical documentation and declarations of conformity
• Assist in ensuring required documentation and statements for performance studies are prepared and maintained in alignment with Annex XIV and Article 15 responsibilities
• Perform additional duties as assigned to support regulatory and organizational objectives

Benefits

• medical, dental, vision, life, and disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• paid Holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior